(114 days)
The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM3 / AM3 BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics:
- Handheld device
- Battery operation
- Storing capacity of 400 measurements
- Storing capacity of 200 sets of questionnaires (each 12)
- Measurement Parameters: PEF and FEV1
- Accuracy Flow: ± 5% or ± 20 l/min
- Accuracy Volume: ± 3% or ± 0.05 liter
- Data transmission to computer via USB, Bluetooth and Serial
- Flow sensor (single patient use)
- Mouthpiece (single patient use)
The provided document is a 510(k) Summary for the Asthma Monitor AM3 / AM3 BT. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the addition of Bluetooth data transmission. It is not an effectiveness study as typically performed for novel algorithms or diagnostic devices.
Therefore, many of the requested categories for a study proving device performance, especially those related to clinical accuracy, ground truth, and expert evaluation, are not applicable in this context. The document describes engineering and regulatory compliance testing rather than clinical performance studies.
Here's a breakdown of the information that can be extracted or that is not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides performance specifications and indicates that safety and EMC testing was conducted for the modified device, but it doesn't present a table of acceptance criteria and reported device clinical performance in the way this question typically implies for diagnostic algorithms.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (AM3 / AM3 BT) |
|---|---|---|
| Accuracy Flow | ± 5% or ± 20 l/min | Identical (implied, per substantial equivalence to predicate which had this spec) |
| Accuracy Volume | ± 3% or ± 0.05 liter | Identical (implied, per substantial equivalence to predicate which had this spec) |
| Data Transmission | Serial RS 232 & USB | Serial RS 232 & USB & Bluetooth (additional) |
| Bluetooth Module | (Specifics for AM1+ BT predicate: WML-C46) | Identical (WML-C46) |
| Safety Testing | Satisfaction of all safety requirements and mitigation of all identified hazards | Demonstrated satisfaction of all safety requirements and mitigation of all identified hazards |
| EMC Testing | Compliance with EN 60601-1-2 | Performed according EN 60601-1-2 |
| Software Dev. | Compliance with IEC 601-1-4 Standard | Developed according to IEC 601-1-4 Standard |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission focuses on engineering modifications (adding Bluetooth) and demonstrating equivalence to existing devices, not on a clinical performance study with a "test set" of patient data for algorithm evaluation in the way the question implies. The testing done was likely functional and safety testing of the device hardware and software.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth establishment by medical experts for a test set is described or required for this type of 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication is relevant to this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI/algorithm-focused submission. It's for a diagnostic spirometer with an added data transmission method (Bluetooth).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a measurement device (spirometer), not a standalone algorithm/AI without human input. Its function is to provide quantifiable measurements (PEF, FEV1) to the patient and physician.
7. The Type of Ground Truth Used
Not applicable. Ground truth, in the context of clinical accuracy or diagnostic performance, is not discussed as this submission focuses on device equivalence and safety for a new data transmission method. The "truth" for the device's measurements would be established through mechanical calibration and validation against known standards, not by expert consensus on clinical cases.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned or relevant to this submission.
Summary of the Study Discussed in the Document:
The "study" described in the 510(k) summary is primarily engineering and regulatory compliance testing to support a Special 510(k) submission for a device modification (adding Bluetooth data transmission).
The key elements are:
- Objective: To demonstrate substantial equivalence of the Asthma Monitor AM3 with Bluetooth (AM3 BT) to its predicate device (Asthma Monitor AM3 K980876/A2) and a similar predicate with Bluetooth (Asthma Monitor AM1+ / AM1+ BT K090486), specifically for the added Bluetooth functionality.
- Methodology:
- Comparison: A direct comparison table shows the characteristics of the new AM3 BT against the original AM3 and the AM1+ BT. The critical point is that the Bluetooth module in the AM3 BT is identical to the one used in the already cleared AM1+ BT.
- Development Standards: The Bluetooth data transmission was developed in accordance with Cardinal Health's standard operating procedures (Design Control).
- Risk Analysis: A Failure Modes and Effects Analysis (FMEA) was performed to assess the impact of the added Bluetooth.
- Safety Testing: Procedures were followed to demonstrate satisfaction of all safety requirements and mitigation of identified hazards.
- EMC Testing: Performed according to EN 60601-1-2.
- Software Development: Followed IEC 601-1-4 Standard.
- Conclusion: Based on these engineering and regulatory compliance measures, the submitter concluded that the Asthma Monitor AM3 with the "Bluetooth" data transmission module is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, performing at least as well as the predicate devices.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).